IMPORTANT SAFETY INFORMATION
After starting YESINTEK, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. YESINTEK can make you more likely to get infections or make an infection that you have worse.
People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take YESINTEK may also be more likely to get these infections.
Cancers: YESINTEK may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who are receiving ustekinumab products and have risk factors for skin cancer developed certain types of skin cancers. During your treatment with YESINTEK, tell your doctor if you have any new skin growths.
Posterior Reversible Encephalopathy Syndrome (PRES): PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including headache, seizures, confusion, and vision problems.
Serious Allergic Reactions: Serious allergic reactions can occur with YESINTEK. Stop using YESINTEK and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Lung Inflammation: Cases of lung inflammation have happened in some people who receive ustekinumab and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with YESINTEK.
Common side effects of YESINTEK include: nasal congestion, sore throat, and runny nose, redness at the injection site, upper respiratory infections, vaginal, yeast infections, fever, urinary tract infections, headache, sinus infection, tiredness, bronchitis, itching, diarrhea, nausea and vomiting, stomach pain. These are not all of the possible side effects with YESINTEK. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.
Before you receive YESINTEK, tell your doctor about all of your medical conditions, including if you:
- have any of the conditions or symptoms listed above for serious infections, cancers, or PRES.
- ever had an allergic reaction to ustekinumab or any of its ingredients. Ask your doctor if you are not sure.
- have recently received or are scheduled to receive an immunization (vaccine). People who take YESINTEK should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving YESINTEK or one year after you stop receiving YESINTEK.
- have any new or changing lesions within psoriasis areas or on normal skin.
- are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with YESINTEK. YESINTEK may also increase your risk of having an allergic reaction to an allergy shot.
- receive or have received phototherapy for your psoriasis.
- are pregnant or plan to become pregnant. It is not known if YESINTEK can harm your unborn baby. You and your doctor should decide if you will receive YESINTEK.
- received YESINTEK while you were pregnant. It is important that you tell your baby’s healthcare provider before any vaccinations are given to your baby.
- are breastfeeding or plan to breastfeed. YESINTEK can pass into your breast milk.
- talk to your doctor about the best way to feed your baby if you receive YESINTEK.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed YESINTEK:
- Use YESINTEK exactly as your doctor tells you to.
- Adults with Crohn’s disease and ulcerative colitis will receive the first dose of YESINTEK through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. You will then receive YESINTEK as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of YESINTEK, as described below.
- Adults with psoriasis or psoriatic arthritis, and children 6 years and older with psoriasis or psoriatic arthritis will receive YESINTEK as an injection under the skin (subcutaneous injection) as described below.
Injecting YESINTEK under your skin:
- YESINTEK is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that YESINTEK be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of YESINTEK at home, you should receive training on the right way to prepare and inject YESINTEK. Your doctor will determine the right dose of YESINTEK for you, the amount for each injection, and how often you should receive it. Do not try to inject YESINTEK yourself until you or your caregiver have been shown how to inject YESINTEK by your doctor or nurse.
- Inject YESINTEK under the skin (subcutaneous injection) in your upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).
- Do not give an injection in an area of the skin that is tender, bruised, red or hard.
- Use a different injection site each time you use YESINTEK.
- If you inject more YESINTEK than prescribed, call your doctor right away.
- Be sure to keep all of your scheduled follow-up appointments.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch
or call 1-800-FDA-1088.